Coronary Artery Disease
Conditions
Keywords
dedicated bifurcation stent, non-LM bifurcation, sirolimus-eluting stent
Brief summary
Coronary bifurcations are encountered in about 15 - 20% of percutaneous coronary interventions (PCI). They are considered technically challenging and associated with worse clinical outcomes than non-bifurcation lesions. Percutaneous coronary intervention (PCI) to the target bifurcation lesion. Randomization (by means envelope randomization) to investigational device: Group 1 for BiOSS LIM C implantation vs Group 2 for any DES implantation.
Detailed description
Single stent implantation in the main vessel-main branch across a side branch is the default strategy (provisional T-stenting, PTS) in all patients enrolled. Bifurcation lesions are assessed according to Medina classification using an index of 1 for stenosis greater than 50% and 0 for no stenosis (visual estimation). There is no restriction regarding lesion length in patient selection. If required, additional stent can be implanted (Alex Plus in the BiOSS Lim C Group). A stent in a side branch (Alex Plus in the BiOSS Lim C Group) should be implanted only if there is proximal residual stenosis greater than 70% after balloon dilatation and/or significant flow impairment after main vessel - main branch stenting and/or a flow limiting dissection. The implantation protocol for bifurcation is as follows: 1. wiring of both branches; 2. main vessel predilatation and/or side branch predilatation according to the operator's decision; 3. stent implantation (inflation for at least 20 s); 4. proximal optimization technique (POT) 5. side branch postdilatation/side branch stent implantation if necessary 6. final kissing balloon inflation at operator's discretion. 7. Second proximal optimization technique (re-POT)
Interventions
PCI with BiOSS LIM C or rDES depending on the randomization
Sponsors
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject at least 18 years of age. 2. Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. 3. Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm. 4. Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.
Exclusion criteria
1. Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment). 2. Subjects who refuse to give informed consent. 3. Subjects with LVEF\<30% 4. Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy 5. Distal LM stenosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 12 months | Major Cardiovascular Events rate (cardiac death, myocardial infarction, target lesion revascularization); |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause death | 12 months | All cause death |
| cardiac death | 12 months | cardiac death |
| myocardial infarction | 12 months | myocardial infarction |
| target lesion revascularization | 12 months | target lesion revascularization |
Countries
Poland
Outcome results
None listed